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Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-93

  1. 2,261 Posts.
    lightbulb Created with Sketch. 367
    I agree my interpretation is the same as OP, this addresses the concerns and links the requirements back to the existing P3 trial data thus renedering the need for an additional trial redundant. Move on to BLA.
 
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